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GNC and NY AG Announce Agreement on DNA Testing of Herbal Supplements

CLARIFICATIONApreviousversionofthispressreleasewasissuedbyABCafewhoursago.ThatversioninadvertentlymischaracterizedwhatABCFounderandExecutiveDirectorMarkBlumenthaltolda NewYorkTimes reporterinaninterviewyesterday.TheTimesandtheABCreleaseincorrectlystate thatBlumenthalsaidthatadulterationofherbalingredientsinsomeoftheherbalsupplementstestedbytheNewYorkAttorneyGeneralwere “likely”;thetermheusedis “possibly,”asadulterationisknowntoexistinsomeoftheimplicatedherbs.Mr.Blumenthalhasnotyetseenanyresultsfromindependentlabtestingoftheimplicatedproductsandthuscannotpredictthelikelihoodofwhethertheymaybeadulterated.ABClamentsanyconfusionthismayhavecaused.

(AUSTIN,Texas,March30,2015)TheNewYorkTimestodaypublishedfront-pagearticlebyreporterAnahadO’ConnorthatdescribeselementsofanagreementbetweenNewYorkAttorneyGeneral(NYAG)EricT.Schneiderman’sofficeandGNCofPittsburgh,PA,relatedtotheAG’spreviousinvestigationintoherbaldietarysupplementssoldbyGNC.IntheagreementGNChasagreedtoemployDNAbarcodetestinginallofitscrudebotanicalingredientstobeusedinherbaldietarysupplementswithin18months.1Mr.O’ConnorinitiallybrokethestorywithhisarticleonFebruary3describingtheNYAG’shavingsentcease-and-desistletterstoGNCaswellasWalgreens,Walmart,andTargetforallegedlysellinghousebrandsofherbaldietarysupplementsthattheNYAGhaddeterminedthelistedingredientswereabsentfromabout80%oftheproducts.2Thismorning’sNewYorkTimesarticlequotesGNCCEOMichaelG.Archboldasstating,“Asourtestingdemonstrated,andthisagreementaffirmsbeyondanydoubt,ourproductsarenotonlysafeandpurebutareinfullcompliancewithallregulatoryrequirements.”Mr.ArchboldwasreferringtoanannouncementthatGNChadmadeearlierthismonththatitsindependenttestinghadconfirmedtheauthenticityoftheingredientsintheeffectedherbalsupplements.3,4ThismorningGNCissuedapressreleaseannouncingtheagreementalthoughspecificdetailswerenotgiven.5TheAmericanBotanicalCouncil’sFounderandExecutiveDirectorMarkBlumenthalwasinterviewedbyMr.O’ConnoronSunday.Theone-hourinterviewcoveredmanyaspectsofthebackgroundofthisissue,includingthecapabilities,limitations,andproblemsassociatedwithDNAbarcodingintestingtheauthenticityofbotanicalextracts,theneedforconfirmatorytestingbyusingotherscientificallyvalidtestmethods,andmuchmore.BlumenthalemphasizedtoMr.O’Connorthathighlyreputableexpertsinindustry,academia,independentnonprofitresearchandstandards-settingorganizations,andgovernmentagencieshavecastsignificantandseriousdoubtontheAG’srelianceontheDNAbarcodingmethodusedatClarksonUniversityasthesoletestmethodutilized,particularlywhensuchmethodsareunreliablefortestingbotanicalextracts,ofwhichabout76%ofthetestedproductswerelabeled.Thus,saidBlumenthalonseveraloccasionsintheinterview,withoutanyfulldisclosureandtransparencyonthepartoftheNYAG,seriousscientistsandotherscannotrelyontheunusualandnon-credibletestresultsuponwhichtheNYAGbaseditslegalactions.AkeypointmadebyBlumenthalintheinterviewwithMr.O’Connor,butnotmentionedinthearticle,isthatthereappearedtobeafalsepresumptionthatGNChadagreedtowhataremostlikelytheAG’sstipulatedtermsbecauseGNChadbeenseenassellingsubstandardherbaldietarysupplements.Infact,intheagreementthereisreportedlynoadmissionofwrongdoingonbehalfofGNCand,asBlumenthalpointedout,analyticalexpertsandothershaveraisedseriousdoubtsabouttheconclusionsthathavebeendrawnonthefaultyapplicationofDNAbarcodetechnologytoGNC’sproducts,whichwereallbotanicalextracts.BlumenthaltoldO’ConnorthatdespitethisgrowingviewthattheNYAG’stestsresultswerenotvalid,thatindependenttestingofproductssimilartothosethatweretestedbytheAGcouldpossiblyrevealproblemswithsomeoftheproducts,asABCisawareofadulterationproblemsassociatedwithsomeoftheherbcategories,particularlyginkgoextractandSt.John’swortextract.Thearticleincludesthefollowingstatementsbasedontheinterview:

MarkBlumenthal,theexecutivedirectoroftheAmericanBotanicalCouncil,anonprofitorganizationthatpromotestheuseofherbalproducts,saidhebelievedthatthesupplementsincludedintheinvestigationmostlikely[thetermintheinterviewwas"possibly"]sufferedfromsomelevelofadulteration—anestablishedproblemintheindustry—butnottotheextentsuggestedbytheattorneygeneral.Hecriticizedtheattorneygeneral’stestingproceduresandsaidhisstudydatashouldbemadepublic.Mr.BlumenthalsaidheapplaudedGNCforreachinganagreementwithNewYorkandputtingnewproceduresintoeffect,buthealsoworriedthatactionsatthestatelevelcouldcreate“apatchworkquiltofdifferentqualitystandardsandrequirements”acrossthecountry.“I’mconcernedthatthiscanpotentiallyleadtovariousstandardsbeingsetupindifferentstatesandthat’salegitimateissuefortheindustryandconsumers,”hesaid.

Intheinterview,Blumenthalalsonotedthefollowingpoints,amongothers,thatwerenotmentionedintheTimesarticle:
  • NYAGappearstobeattemptingtoestablishnewtestingrequirementsbeyondwhatisrequiredbytheUSFoodandDrugAdministration’s(FDA)GoodManufacturingPractices(GMP)rule.ThiswouldbetheresponsibilityoftheFDA,notanindividualstateagency.
  • ItappearsthattheNYAGisdoublingorperhapstriplingdownonitsintransigencewithrespecttoitunscientificanduntenablepositiononrelyingononlyoneDNAbarcodingtestuponwhichithasmadeitsentirecaseandpublicitycampaign.BystipulatingthatGNCadoptandadherespecificallytoDNAbarcoding-basedtestingmethods,theNYAGappearstobetryingtovalidatehisconclusionsbasedsolelyoninadequateDNAtestingofherbaldietarysupplementswithoutfurtherverificationoftheresultsbystandardchemically-basedmethods,whichhasbeencriticizedinseveralrecentlypublishedwhitepapers,andalsobyinferencebyaletterfromtheFDA.ItisnotclearatthistimeastowhichherbaldietarysupplementsproductsofGNC’s,ifany,maybeoutofcompliancewithlabelclaimsregardingtheiridentity,whichwouldgivetheAGsufficientleveragetoforceGNCtoagreetothetermsofthereportedagreement.Thus,itisnotcleartoABCwhyGNChasagreedtothestatedterms.Hestressedthat,ofthefourcompaniestowhichcease-and-desistlettersweresentbytheNYAGinFebruary,GNCistheonlycompanytoABC’sknowledgethatpurchasesitsownrawmaterialsandextractsandprocessesthemintodietarysupplementsinitsownfacilities.Therefore,GNCisnotdependentonthird-partycontractmanufacturersandhassignificantlymorecontroloveritspurchasingandmanufacturingprocessesthantheothercompanies,allowingGNCtonegotiatetermswiththeNYAGtowhichitbelievesitcanadhereandcomply.GNC’sagreementtoutilizeDNAtestingonbotanicalrawmaterialstodeterminetheiridentitypriortotheirbeingextractedsuggeststhattheNYAGnowappearstohaverealizedthatDNAtestingisnotsuitableorfitforpurposefortheextractsthemselves,eventhoughtheNYAG’sofficehasnotpubliclyacknowledgedsuchanowwell-knownfact.
  • GNCdoesnotproduceitsownbotanicalextracts.TherequirementthatGNCstipulatethatitsextractsuppliersutilizeDNAtestmethodsonbotanicalrawmaterialstoauthenticatetheiridentitycanhelpensurethattheextractorisusingcorrectbotanicalmaterialsforextraction.However,Blumenthalnotedthatitisquitepossiblethatsomehigh-qualityextractorsintheinternationalmarketmayalreadyuseDNAbarcodingwithotheranalyticalmethods.But,heemphasized,itdoesnotmeanthatifthisweretobecomeastandardindustrypractice,astheNYAGappearstobepromoting,thatapotentiallyunscrupulousextractorcouldstillsubsequentlymanipulatetheextractinsuchawayastocreateafalsesenseofvalue,i.e.,adulterateitwithotherextractsand/oradditionalunlabeledchemicalcompounds,naturalorsynthetic,fromothersources.DNAtestingwillnotbeabletodetectsuchchangesinthechemicalcomposition;onlyappropriatechemicaltestingmethods,asiscurrentlyusedinmanypartsofthebotanicalindustry,candothis.Inaddition,DNAbarcodetestingcanbeeasilyfooledbyaddingafewsprinklesofauthenticplantmaterialtoanotherwiseunacceptablematerialand,therefore,cannotguaranteebyitselfthequalityofaningredientorsupplement.

ABChasnotyetbeenabletoobtainacopyofthefinalagreement.AccordingtomaterialsuppliedtoABCbytheNewYorkTimes,someofthetermsoftheGNCagreementwiththeNYAGareasfollows:

  • GNCagreestoroutinelytestforvariouspotentialcontaminants(whichisanormallyrequiredprovisionofthecurrentGMPrule),specificallythosethatmaycauseallergicreactions;
  • GNCagreestothestipulationthat“allherbalingredientsusedinitsproductsaremanufacturedinfacilitiesthatarecertifiedasgoodmanufacturingcompliantbyathird-partyaccreditationbody,suchasISO,USP,orNSF”;
  • “Within18months,GNCwillbeginutilizingDNAbarcodingtoconfirmtheauthenticityofallplantsusedassourcesforitsherbalsupplementsproductspriortoprocessing.GNCwillcontributeanynewbarcodes,andthescientificmethodsusedtoidentifythem,toapubliclyaccessibledatabasewithin24months”;
  • “GNCwillprominentlydisplaysignsinstoresacrossthecountryandonitswebsitethatexplainthedifferencebetweenwholeherbsandextracts”;
  • “GNCwillprovidesemiannualreportstotheAttorneyGeneral’sOffice,detailingallplantspeciessourcedafterauthenticationusingDNAbarcoding;thenameandaddressofallfacilitiesinwhichDNAbarcodeauthenticationwasperformed;alistofmaterialsrejectedasaconsequenceoftheresultsofthebarcodingandtheresultsoftherandomizedtestingforcommonallergens.”
OtherpersonsquotedinthearticleincludePieterCohen,MDofHarvard,andDavidSchardtoftheCenterforScienceinthePublicInterest.

ThenewGNCagreementwasalsothesubjectofthismorning’s“Marketplace”segmentonNationalPublicRadio’sMorningEdition,and,presumably,othermediahasbeenandwillbereportingandmisreportingonthisdevelopmentforatleastthenextfewdays,orlonger.

AcomprehensivearticleonthisissuesincetheNYAG’sFebruary3announcementwaspublishedinABC’smonthlye-newsletterHerbalEGraminMarch,availablehere.6

1.O’ConnorA.GNCtoStrengthenSupplementQualityControls.NewYorkTimes.March30,2015.Availableat:http://well.blogs.nytimes.com/2015/03/30/gnc-to-strengthen-supplement-quality-controls/?&hp&action=click&pgtype=Homepage&module=first-column-region&region=top-news&WT.nav=top-news.AccessedMarch30,2015.

2.O’ConnorA.4RetailersToldtoStopSellingSupplements:TestsFindFillers,NotMedicinalHerbs[printversion];NewYorkAttorneyGeneralTargetsSupplementsatMajorRetailers[onlineversion].NewYorkTimes,Feb3,2015.Availableat:http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=0.AccessedMarch30,2015.

3.GNCHoldings.GNCRefutesNewYorkStateAttorneyGeneral’sClaimsinFullandRobustResponse.BusinessWire.February9,2015.Availableat:www.businesswire.com/news/home/20150209006388/en/GNC-Refutes-York-State-Attorney-General’s-Claims#.VRk2GULQBJ1.AccessedMarch30,2015.

4.ArmentalM.GNCSaysOutsideTestingofNutritionalSupplementsFoundNoImproperLabeling.WallStreetJournal.March10,2015.Availableat:www.wsj.com/articles/gnc-says-outside-testing-of-nutritional-supplements-found-no-improper-labeling-1426033941.AccessedMarch30,2015.

5.GNCHoldings.GNCReachesAgreementwithNewYorkAttorneyGeneral.BusinessWire.Availableat:http://www.businesswire.com/news/home/20150330005372/en/GNC-Reaches-Agreement-York-Attorney-General#.VRkzuELQBJ0.AccessedMarch30,2015.

6.SmithT.AReviewoftheNewYorkAttorneyGeneral'sRecentActionsagainstHerbalDietarySupplements.HerbalEGram.March2015;12:3.Availableat:http://cms.herbalgram.org/heg/volume12/03March/NYAG_HerbalSupplement_InvestigationReview.html.AccessedMarch30,2015.